EZETIMIBE 10 mg/10 mg Coated Tablet

Содержание инструкции

1. Ezetimibe and Simvastatina Zentiva 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets
   1. What Ezetimibe and Simvastatina Zentiva is and what it is used for
   2. What you need to know before taking Ezetimibe and Simvastatina Zentiva
   3. How to take Ezetimibe and Simvastatina Zentiva
   4. Possible side effects
   5. How to store Ezetimibe and Simvastatina Zentiva
   6. Contents of the pack and other information

Ezetimibe and Simvastatina Zentiva 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ezetimibe and Simvastatina Zentiva is and what it is used for
• 2. What you need to know before you take Ezetimibe and Simvastatina Zentiva
• 3. How to take Ezetimibe and Simvastatina Zentiva
• 4. Possible side effects
• 5. How to store Ezetimibe and Simvastatina Zentiva
• 6. Contents of the pack and other information

1. What Ezetimibe and Simvastatina Zentiva is and what it is used for

Ezetimibe and Simvastatina Zentiva contains the active ingredients ezetimibe and simvastatin.
Ezetimibe and Simvastatina Zentiva is a medicine that is used to decrease the levels
of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called
triglycerides in the blood. In addition, Ezetimibe and Simvastatina Zentiva increases the levels of
“good” cholesterol (HDL cholesterol).
Ezetimibe and Simvastatina Zentiva works in 2 ways to lower cholesterol. The active
ingredient ezetimibe reduces the cholesterol absorbed in the digestive tract. The active
ingredient simvastatin, which belongs to the class of “statins”, inhibits the production of cholesterol
synthesized by the body.
Cholesterol is one of the various fatty substances found in the bloodstream. Total
cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can accumulate
in the walls of the arteries forming plaques. Over time, this
accumulation in the form of plaque can lead to a narrowing of the arteries. This
narrowing can slow down or block the flow of blood to vital organs such as the heart and
brain. This blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps prevent
bad cholesterol from accumulating in the arteries and protects against heart disease.
Triglycerides are another form of fat present in the blood that can increase the risk
of heart disease.
Ezetimibe and Simvastatina Zentiva is used for patients who cannot keep their cholesterol levels under
control with diet alone. While taking this medicine
you should still follow a diet to lower cholesterol.
Ezetimibe and Simvastatina Zentiva is used as an adjunct to diet therapy to lower
cholesterol if you have:

• increased cholesterol levels in the blood (primary hypercholesterolemia) [familial and non-familial heterozygous] or high levels of fats in the blood (mixed hyperlipidemia):
• which are not well controlled by a statin alone
• for which you have taken treatment with a statin and ezetimibe in separate tablets
• an inherited disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be receiving other treatments.
• heart disease, Ezetimibe and Simvastatina Zentiva reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe and Simvastatina Zentiva does not help with weight loss.

2. What you need to know before taking Ezetimibe and Simvastatina Zentiva

Do not take Ezetimibe and Simvastatina Zentiva if

• you are allergic to ezetimibe, simvastatin or any of the other ingredients of this medicine (listed in section 6)
• you currently have liver problems
• you are pregnant or breastfeeding
• you are taking any medicine(s) containing one or more of the following active substances:
• itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections).
• erythromycin, clarithromycin or telithromycin (used to treat infections).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infections).
• boceprevir or telaprevir (used to treat hepatitis C virus infections).
• nefazodone (used to treat depression).
• cobicistat
• gemfibrozil (used to lower cholesterol).
• cyclosporine (often used in patients who have undergone organ transplantation).
• danazol (a hormone produced by man used to treat endometriosis, a condition in which the lining of the uterus develops outside the uterus).
• you are taking or have taken, in the last 7 days, a medicine called fusidic acid (a medicine used to treat bacterial infection) orally or by injection. The combination of fusidic acid and Ezetimibe and Simvastatina Zentiva can cause serious muscle problems (rhabdomyolysis).
• Do not take more than 10 mg/40 mg of Ezetimibe and Simvastatina Zentiva if you are taking lomitapide (used to treat a severe and rare genetic condition of cholesterol).

Ask your doctor for advice if you are not sure whether the medicine you are taking is among those
listed above.

Warnings and precautions
Tell your doctor or pharmacist before taking Ezetimibe and Simvastatina Zentiva if:

• you suffer from any medical condition, including allergies.
• you consume significant amounts of alcohol or if you have ever had a liver disease. In this case Ezetimibe and Simvastatina Zentiva may not be suitable for you.
• you are going to have surgery. You may need to stop taking Ezetimibe and Simvastatina Zentiva tablets for a short period.
• you are Asian, because a different dose may be appropriate for you.
• you have a severe lung disease.

The doctor must have your blood tested before giving you Ezetimibe and
Simvastatina Zentiva and if you have symptoms of liver problems while taking Ezetimibe and
Simvastatina Zentiva. This test is done to know if the liver is working
properly.
The doctor may prescribe blood tests to check liver function also after
starting therapy with Ezetimibe and Simvastatina Zentiva.
During treatment with this medicine, the doctor will carefully monitor that you do not
have diabetes or are at risk of developing diabetes. You may be at risk of
developing diabetes if you have high levels of sugars and fats in your blood, if you are overweight and
have high blood pressure.
The concomitant administration of Ezetimibe and Simvastatina Zentiva and fibrates (some types
of medicines to lower cholesterol) should be avoided as the concomitant use
of Ezetimibe and Simvastatina Zentiva and fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness and
muscle weakness. This is because, rarely, muscle problems
can be serious and include muscle tissue damage that causes kidney damage;
very rarely, deaths have occurred.
The risk of muscle injury is greater at higher doses of Ezetimibe and Simvastatina
Zentiva, particularly with the 10 mg/80 mg dose. The risk of muscle injury is greater
also in some patients. Tell your doctor if any of the following conditions apply to
you:

• you have kidney problems.
• you have thyroid problems.
• you are 65 years of age or older.
• you are female.
• you have ever had muscle problems while taking cholesterol-lowering medicines called “statins” (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil and bezafibrato).
• you or your close family members suffer from a hereditary muscle disease.

Also, tell your doctor or pharmacist if you have a constant muscle weakness. Further
tests and medicines may be needed for the diagnosis and treatment of this
condition.

Children and adolescents
The use of Ezetimibe and Simvastatina Zentiva is not recommended in children under the age of
10 years.

Other medicines and Ezetimibe and Simvastatina Zentiva
Tell your doctor if you are taking, have recently taken or might take any
other medicine with any of the following active substances. Taking Ezetimibe and
Simvastatina Zentiva with any of the following medicines may increase the risk of
muscle problems (some have already been mentioned above in the “Do not take Ezetimibe and
Simvastatina Zentiva” section).

• If you need to take fusidic acid orally to treat a bacterial
  infection, you will have to temporarily stop taking this medicine. The
  doctor will tell you when it is safe to start treatment with Ezetimibe and
  Simvastatina Zentiva again. Taking Ezetimibe and Simvastatina Zentiva with
  fusidic acid can rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more information on rhabdomyolysis in
  section 4.
• Cyclosporine (often used in patients receiving an organ transplant).
• Danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus develops outside the uterus).
• Medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections).
• Fibrates with active ingredients such as gemfibrozil and bezafibrato (used to reduce cholesterol).
• Erythromycin, clarithromycin or telithromycin (used to treat bacterial infections).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS).
• Antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection).
• Nefazodone (used to treat depression).
• Medicines with the active ingredient cobicistat.
• Amiodarone (used to treat an irregular heartbeat).
• Verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart diseases).
• Lomitapide (used to treat a severe and rare genetic cholesterol condition.
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). It is possible that adverse effects on the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g. Ezetimibe and Simvastatina Zentiva). Your doctor may decide to suspend your intake of Ezetimibe and Simvastatina Zentiva for a while.
• High doses (1 g or more per day) of niacin or nicotinic acid (also used to lower cholesterol).
• Colchicine (used to treat gout).

In addition to the medicines listed above, tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those without a prescription.
In particular, tell your doctor if you are taking any of the following:

• medicines with an active ingredient to prevent blood clots, such as warfarin, fluindione, fenprocumone or acenocumarol (anticoagulants).
• cholestyramine (also used to lower cholesterol) as it affects how Ezetimibe and Simvastatina Zentiva works.
• fenofibrate (also used to lower cholesterol).
• rifampicin (used to treat tuberculosis).
• ticagrelor (used to prevent heart attack or stroke).

You should also inform any doctor who is prescribing you a new medicine that
you are taking Ezetimibe and Simvastatina Zentiva.

Ezetimibe and Simvastatina Zentiva with food and drink
Grapefruit juice contains one or more substances that alter the metabolism of some
medicines, including Ezetimibe and Simvastatina Zentiva. Consumption of grapefruit
juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding
Do not take Ezetimibe and Simvastatina Zentiva if you are pregnant, if you are planning
to become pregnant or if you suspect you may be pregnant. If you become pregnant during therapy
with Ezetimibe and Simvastatina Zentiva, stop taking it immediately and contact your
doctor. Ezetimibe and Simvastatina Zentiva should not be used if you are breastfeeding as it is
not known whether the medicine passes into human milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Ezetimibe and Simvastatina Zentiva is not expected to interfere with your ability to
drive or operate machinery. However, you should be aware that some people have experienced
dizziness after taking Ezetimibe and Simvastatina Zentiva.

Ezetimibe and Simvastatina Zentiva contains lactose and sodium
The tablets of Ezetimibe and Simvastatina Zentiva contain a sugar called lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
essentially “sodium-free”.

3. How to take Ezetimibe and Simvastatina Zentiva

Your doctor will determine the appropriate tablet dosage for you, based on your current treatment and your risk profile.
Always take this medicine exactly as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor or pharmacist.

• Before starting to take Ezetimibe and Simvastatina Zentiva, you should have already followed a diet to lower your cholesterol levels.
• During treatment with Ezetimibe and Simvastatina Zentiva, you should continue to follow this cholesterol-lowering diet.

Adults: the dose is 1 tabletorally once a day.

Use in adolescents(ages 10 to 17): the dose is 1 tabletorally once a day (do not exceed a maximum dose of 10 mg/40 mg once a day).
The 10 mg/80 mg dose of Ezetimibe and Simvastatina Zentiva is recommended only in adult patients with very high cholesterol levels and at high risk for heart disease
who have not reached their ideal cholesterol level with lower doses.
If the optimal dosage cannot be achieved using Ezetimibe and Simvastatina Zentiva, your doctor may prescribe you other tablets containing ezetimibe/simvastatin.
The tablets do not have a break line and should not be divided.
Take Ezetimibe and Simvastatina Zentiva in the evening. You can take it with or without food.
If your doctor has prescribed Ezetimibe and Simvastatina Zentiva with another medicine to lower your cholesterol containing the active ingredient colestyramine or any other
bile acid sequestrant, you must take Ezetimibe and Simvastatina Zentiva at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe and Simvastatina Zentiva than you should
Contact your doctor or pharmacist.

If you forget to take Ezetimibe and Simvastatina Zentiva
Do not take a double dose to make up for the missed tablet, just take the normal dose of Ezetimibe and Simvastatina Zentiva the next day at the usual time.

If you stop taking Ezetimibe and Simvastatina Zentiva
Consult your doctor or pharmacist because your cholesterol may increase again.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them (see section 2).
The following side effects have been reported common(may affect up to 1
in 10 people):

• muscle pain
• increases in laboratory blood test values regarding liver function (transaminases) and/or muscles (CK)

The following side effects have been reported uncommon(may affect up to 1
in 100 people):

• increases in liver function blood test values; increases in uric acid levels in the blood; increases in the time it takes for blood to clot; presence of protein in the urine; decrease in body weight
• dizziness; headache; sensation of tingling
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhea; dry mouth; heartburn
• skin rash; itching; hives
• joint pain; muscle pain; sensitivity; weakness or spasms; neck pain; arm or leg pain; back pain
• unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• sleep disorder; difficulty falling asleep

The following side effects have been reported rare(may affect up to 1 person in

• 1,000):
• blurred vision and impaired vision
• a hypersensitivity reaction that included some of the following characteristics: allergic reactions including swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin rashes and swelling, urticaria, skin sensitivity to sunlight, fever, hot flushes, shortness of breath and feeling unwell, a lupus-like illness (including skin rash, joint problems and effects on white blood cells).
• poor memory, memory loss, confusion.

The following side effects have been reported very rare(may affect up to 1
in 10,000):

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)
• gynecomastia (enlargement of the breast in men)
• Skin rash that may occur on the skin or sores in the mouth (drug-induced lichenoid eruptions).
• Muscle rupture.

In addition, the following side effects have been reported with a not knownfrequency (cannot
be estimated from the available data) in people taking
ezetimibe/simvastatin in combination or ezetimibe or simvastatin alone:

• lowering of the number of red blood cells (anemia); decrease in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia).
• loss of sensation or weakness in the arms and legs;
• lung inflammation that causes breathing problems including persistent cough and/or shortness of breath or fever.
• constipation.
• inflammation of the pancreas often with severe abdominal pain.
• inflammation of the stomach.
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes; itching; dark urine or pale stools; feeling tired or weak; loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea and vomiting).
• hair loss; raised, red skin rash, sometimes with target-like lesions (erythema multiforme).
• muscle pain, tenderness, weakness or cramps; muscle injury; tendon problems, sometimes complicated by tendon rupture.
• decreased appetite.
• hot flushes; high blood pressure.
• pain.
• erectile dysfunction.
• depression.
• alteration of some values in blood tests regarding liver function.
• constant muscle weakness.

Further possible side effects reported with some statins:

• sleep disturbances, including nightmares.
• sexual difficulties.
• diabetes. This is more likely if you have high levels of sugar and fat in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Contact your doctor immediately if you experience pain, tenderness and muscle weakness
of unknown cause, as muscle problems can, rarely, be serious and
lead to muscle tissue damage that causes kidney damage and very
rarely cases of death.
Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Ezetimibe and Simvastatina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use Ezetimibe and Simvastatina Zentiva after the expiry date which is stated on the
container after the words “Exp”. The expiry date refers to the last day of that
month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ezetimibe and Simvastatina Zentiva contains
The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of
ezetimibe and 10 mg of simvastatin. Each tablet contains 10 mg of ezetimibe and 20
mg of simvastatin. Each tablet contains 10 mg of ezetimibe and 40 mg of
simvastatin.
The other ingredients are: Tablet core: lactose monohydrate, hypromellose,
sodium croscarmellose, microcrystalline cellulose, ascorbic acid, anhydrous citric acid,
butylhydroxyanisole, propyl gallate, magnesium stearate. Pigment mixture: lactose
monohydrate, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide
(E172).

Description of the appearance of Ezetimibe and Simvastatina Zentiva and contents of the pack
Ezetimibe and Simvastatina Zentiva 10 mg/10 mg tablets are light brown,
mottled, round, with a diameter of 6 mm, biconvex, marked with "511" on one
side.
Ezetimibe and Simvastatina Zentiva 10 mg/20 mg tablets are light brown,
mottled, round, with a diameter of 8 mm, biconvex, marked with "512" on one
side.
Ezetimibe and Simvastatina Zentiva 10 mg/40 mg tablets are light brown,
mottled, round, with a diameter of 10 mm, biconvex, marked with "513" on one
side.
Packs
10 mg/10 mg: 10, 30, 50, 100 and 300 tablets
10 mg/20 mg; 10 mg/40 mg: 30, 50, 100 and 300 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600, Bulgaria
Special Product's Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy

This medicinal product is authorised in the Member States of the European Economic Area with
the following denomination:
Ezimvalla in Denmark;
Ezetimib Simvastatin Zentiva in Germany;
Ezetimibe e Simvastatina Zentiva in Italy;
Ezetimiba + Sinvastatina Zentiva in Portugal;
Cornusan in Slovakia;
Axocar in Poland.